Vascular Access Devices and Methods

ABSTRACT

Some embodiments of a vascular access device are configured to reduce the likelihood of blood leakage during installation, even when the device is optionally installed using a single hand. In particular implementations, the vascular access device is configured as a peripheral intravenous (IV) device.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a divisional of U.S. patent application Ser. No.14/612,043 filed on Feb. 2, 2015 and entitled “Vascular Access Devicesand Methods,” the entire contents of which are fully incorporated hereinby reference.

TECHNICAL FIELD

This document relates to devices and methods for vascular access, suchas a peripheral intravenous (IV) device and method.

BACKGROUND

There are numerous ways and reasons to access a patient's vasculature.Patients may need administration of IV therapy for hydration,antibiotics, other medications, chemotherapy, blood products, and thelike. The type of vascular access device will depend on the patient,diagnosis length of time needed, lifestyle, healthcare worker'spreference, patient's ability and preference, what the device is beingused for, and difficulties relating to using or maintaining the device.

Some peripheral IV devices provide access through a skin opening using acannula-over-needle assembly, in which a flexible plastic cannula isslidably mounted over a metal introducer needle. After the tip of theintroducer needle and cannula are positioned into the patient's targetedblood vessel via venipuncture, the tip of the cannula is advanced insidethe vessel over the needle to the appropriate position and secured. Theintroducer needle is then withdrawn and discarded while the flexiblecannula is retained in its position to provide fluid communication withthe targeted vessel. In some emergency treatment circumstances, bloodmay seep from the vessel, through the cannula, and possibly out of theproximal end of the access device (after the introducer needle iswithdrawn). A user may reduce the likelihood of such blood seepage byapplying finger pressure (with a first hand of the user) to thepatient's skin near the targeted vessel (e.g., a tamponade) until asecondary instrument can be assembled to the proximal end of the accessdevice (using a second hand of the user).

SUMMARY

The innovative vascular access device concepts provided herein can beadapted for implementation in various medical device designs such as,but not limited to, peripheral IV catheters, central percutaneous IVcatheters, and peripherally inserted central catheters (PICC lines). Insome embodiments, the vascular access device is configured to reduce thelikelihood of blood leakage during installation, even when the device isinstalled using a single hand (without requiring an additional hand ofthe user to apply a tamponade). For example, the vascular access devicemay be configured as a peripheral IV catheter assembly (e.g., includingan access cannula device and an introducer needle) that is readilypenetrated through a skin surface and into a targeted vessel, and arepeatably penetratable septum housed in the access cannula device canprevent blood flow to the proximal end of the access cannula deviceduring and after withdrawal of the introducer needle. Moreover, in thisexample, the user may—optionally, with a single hand—withdraw anintroducer needle from the assembly and install a secondary instrumentat the proximal end of the access cannula device that is configured topenetrate the septum for fluid communication between the targeted vesseland the secondary instrument.

Some implementations of a vascular access device may include a catheterassembly, a needle introducer assembly, and a connector assembly. Thecatheter assembly may include a catheter hub, a catheter tube, and aseptum. The catheter tube may be attached to (and extend from) thecatheter hub. Also, the septum may be disposed within an interior spacedefined by the catheter hub. The introducer needle assembly may includean introducer needle hub, an introducer needle, and a needle guard. Theintroducer needle may be attached to (and extend from) the introducerneedle hub. Also, the introducer needle may be configured to penetratethrough the septum and to extend distally of a distal end of thecatheter tube. The introducer needle may be slidably withdrawable fromthe septum and the catheter tube. The connector assembly may include aconnector body and a connector needle attached to and extending from theconnector body. The connector body may be configured to mate with thecatheter hub after withdrawal of the introducer needle assembly bypressing the connector body into engagement with the catheter hub sothat the connector needle penetrates the septum.

Additional implementations described herein may include a method ofinstalling a vascular access device. The method may include piercing adistal tip of an introducer needle through a skin surface andpositioning the distal tip in a blood vessel while the introducer needleis slidably disposed with a lumen of a catheter assembly such that adistal tip of the catheter assembly is also positioned in the bloodvessel. Also, the method may include withdrawing the introducer needlefrom the patient while leaving the catheter assembly positioned in theblood vessel. The introducer needle may be slidably withdrawn through asealing septum housed within the catheter assembly such that the septumseals a blood flow path through the catheter assembly after theintroducer needle disengages the septum and the catheter assembly. Themethod may further include mounting a connector assembly with thecatheter assembly into an operative configuration by pressing aconnector body of the connector assembly into engagement with a catheterhub of the catheter assembly so that a connector needle of the connectorassembly penetrates through the sealing septum previously occupied bythe introducer needle.

Particular implementations described herein include a vascular accessdevice that may include a catheter assembly, an introducer needleassembly, and (optionally) a connector assembly. The catheter assemblymay include a catheter hub, a catheter tube, and a septum disposedwithin an interior space defined by the catheter hub. Also, theintroducer needle assembly may include an introducer needle, and theintroducer needle may be configured to penetrate through the septum andto be slidably withdrawable from the septum. Optionally, the connectorassembly may include a connector body and a connector needle attached toand extending from the connector body. The connector body may beconfigured to mate with the catheter hub by pressing the connector bodyinto engagement with the catheter hub so that the connector needlepenetrates the septum.

Some or all of the embodiments described herein may provide one or moreof the following advantages. First, some embodiments of the vascularaccess devices may be configured for one-handed operation. For example,some embodiments eliminate the need for a healthcare worker to use asecond hand for applying a tamponade during installation of the vascularaccess device. As such, the vascular access devices are both effectiveand efficient for healthcare workers to use, especially during emergencymedical treatments where blood seepage might otherwise occur. Inaddition, one-handed installation allows the healthcare worker topotentially use his or her other hand to attend to other aspects ofmedical care treatment.

Second, some embodiments of the vascular access devices substantiallyprevent blood leakage during installation. Some such embodiments includea resilient septum (seal) in the catheter hub that substantiallyprevents blood from leaking or squirting out from the IV catheter priorto connecting the catheter hub to another device. Blood is thereforeless prone to contact and contaminate gloves, clothing, shoes, bedding,floors, equipment, and exposed parts of the healthcare worker's body.Accordingly, some risks to healthcare workers associated with exposureto the patient's blood can be potentially mitigated. In addition,cleanliness of the healthcare setting is better maintained. Therefore,the time and expenses related to cleanup of the healthcare setting arereduced.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a cross-sectional side view of a vascular access device thatis in the process of being installed in a patient in accordance withsome embodiments.

FIGS. 2A-B are cross-sectional side views of a portion of the vascularaccess device of FIG. 1.

FIGS. 3A-C are perspective views of the vascular access device of FIG. 1during an example process of using the vascular access device, inaccordance with some embodiments.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Referring to FIG. 1, some embodiments of a vascular access device 100can be used to access a blood vessel 20 through the skin surface 10 of apatient. The vascular access device 100 in the depicted embodimentcomprises multiple components, including a catheter assembly 110, aconnector assembly 160. As described further below (e.g., refer to FIG.3A), the vascular access device 100 may also comprise other componentssuch as an introducer needle assembly and a protective sheath for theintroducer needle assembly 300. In this particular embodiment depictedin FIG. 1, the vascular access device 100 is configured as a peripheralIV catheter assembly that is readily penetrated through the skin surface10 and into a blood vessel 20, and the catheter assembly 110 houses apenetratable sealing septum 130 that is configured to prevent bloodseepage to the proximal end of the access cannula device during andafter withdrawal of the introducer needle (described in more detailbelow in connection with FIGS. 3A-C). Also, in this particularembodiment depicted in FIG. 1, the catheter assembly 110 is configuredto mate with a secondary instruments (e.g., the connector assembly 160in this example) using a single-handed, snap-fit connection such thatthe septum 130 (which was previously penetrated by the introducer needleuntil the needle was withdrawn) is penetrated again to open a fluid pathbetween the targeted vessel 20 and the secondary instrument 160.

In this embodiment, the connector assembly 160 is releasably attachableto the catheter assembly 110. For example, a user may simultaneouslygrasp the catheter assembly 110 and the connector assembly 160 with asingle hand to conveniently press them together in a mating position.When the connector assembly 160 is coupled with the catheter assembly110, and when at least a distal end portion of the catheter assembly 110is in the blood vessel 20 (e.g., as shown), fluid communication existsbetween the blood vessel 20 and the connector assembly 160. Accordingly,fluids such as medications can be infused into the blood vessel 20 viathe connector assembly 160. In another example usage mode, a bloodsample from the blood vessel 20 can be taken via the connector assembly160. It should be understood that the view of the skin surface 10 andblood vessel 20 are not drawn to scale (magnified for purposes ofillustration in FIG. 1) relative to the vascular access device 100.Furthermore, it should be understood from the description herein thatthe vascular access devices 100 are scalable to a range of sizes,including adult and pediatric sizes. In some embodiments, the vascularaccess devices provided herein have multiple lumens

As described further below, when the connector assembly 160 is notattached to the catheter assembly 110 (e.g., as shown), the septum 130of the catheter assembly 110 is positioned to provide a seal thathinders blood seepage from the catheter assembly 110. Hence, thevascular access device 100 is configured to be installed in a patientwithout needing to apply a tamponade force on the skin surface 10 of thepatient prior to coupling the connector assembly 160 with the catheterassembly 110. As such, the vascular access device 100 can be installedusing a one-handed installation method.

Still referring to FIG. 1, the catheter assembly 110 includes a catheterhub 120 and a catheter tube 140. The catheter tube 140 is attached toand extends distally from the catheter hub 120. The catheter hub 120comprises a female connector body 122 and a resilient septum 130disposed therein. The resilient septum 130 is arranged within aninterior space defined by the female connector body 122 such that theinterior space is divided into a distal interior space 121 a and aproximal interior space 121 b, with the resilient septum 130 locatedtherebetween.

The catheter tube 140 defines at least one lumen. The at least one lumenof the catheter tube 140 conflates with the distal interior space 121 adefined by the catheter hub 120. Accordingly, fluid communication canexist from the blood vessel 20, through the catheter tube 140, to thedistal interior space 121 a. As described further below, the resilientseptum 130 is configured to occlude fluid flow through the catheterassembly 110 when the connector assembly 160 is decoupled from thecatheter assembly 110. That is, while the distal interior space 121 a ofthe catheter hub 120 is confluent with the catheter tube 140, theproximal interior space 121 b is not in fluid communication with thecatheter tube 140 when the connector assembly 160 is decoupled from thecatheter assembly 110. However, when the connector assembly 160 iscoupled with the catheter assembly 110, the resilient septum 130 ispierced by the connector assembly 160, and then fluid flow through thevascular access device 100 is facilitated.

The connector assembly 160 includes a male connector body 162, aconnector needle 170, and a connector tube 180. The connector needle 170is attached to and extends distally from the male connector body 162.The connector needle 170 defines at least one lumen. The at least onelumen of the connector needle 170 conflates with an open interior space161 defined by the male connector body 162. The connector tube 180 isalso attached to and extends from the male connector body 162. Theconnector tube 180 defines at least one lumen. The at least one lumen ofthe connector tube 180 conflates with the open interior space 161defined by the male connector body 162. Accordingly, fluid communicationexists from the connector needle 170, through the male connector body162, to the connector tube 180. One of ordinary skill in the art willunderstand that while one end of the connector tube 180 is attached tothe male connector body 162, the other end of the connector tube 180 canbe attached to a variety of types of fittings, containers, devices, andthe like.

As described further below, when the connector assembly 160 is coupledwith the catheter assembly 110, fluid communication exists from theconnector tube 180, through the connector assembly 160 and catheterassembly 110, to the blood vessel 20. Hence, the vascular access device100 is then functional for infusing liquids to the blood vessel 20, orwithdrawing blood from the blood vessel 20. To attain such anarrangement, the connector needle 170 pierces through the resilientseptum 130. Liquids can then freely flow through vascular access device100, rather than being occluded by the resilient septum 130.

Referring now also to FIGS. 2A-B, some embodiments of the connectorassembly 160 can be configured to provide a snap-fit, sealing engagementwith the catheter assembly 110. While FIG. 1 shows the connectorassembly 160 entirely decoupled from the catheter assembly 110, FIG. 2Ashows the connector assembly 160 partially mated with the catheterassembly 110, and FIG. 2B shows the connector assembly 160 fully matedwith the catheter assembly 110. Hence, the series of those three figuresare provided to describe the process of coupling the connector assembly160 with the catheter assembly 110.

When the connector assembly 160 is entirely decoupled the catheterassembly 110, even though the distal end portion of the catheter tube140 is the blood vessel 20, the resilient septum 130 seals the catheterassembly 110 so that no blood leaks from the catheter assembly 110(refer to FIG. 1). To begin the process of coupling the connectorassembly 160 with the catheter assembly 110, in some embodiments ahealthcare worker presses the male connector body 162 into the femaleconnector body 122. In result, the tip of the connector needle 170 isforced to begin piercing the resilient septum 130 (refer to FIG. 2A). Insome embodiments, the proximal interior space 121 b is vented to providea pathway to relieve air pressure from proximal interior space 121 bthat may build up as the male connector body 162 is pressed into thefemale connector body 122.

When the process of coupling the connector assembly 160 with thecatheter assembly 110 is completed, the tip of the connector needle 170has been forced all the way through the resilient septum 130 (refer toFIG. 2B). In the fully coupled configuration, the distal interior space121 a of the catheter hub 120 is in fluid communication with theinterior space 161 of the male connector body 162. Accordingly, thevascular access device 100 is then functional for infusing liquids tothe blood vessel 20, or withdrawing blood from the blood vessel 20.

In some embodiments, the piercing of the resilient septum 130 by theconnector needle 170 is accomplished without causing and/or resulting indeflection of the resilient septum 130. Rather, in some such embodimentsthe piercing of the resilient septum 130 by the connector needle 170results in a compression of the resilient septum 130. Alternatively, insome embodiments the piercing of the resilient septum 130 by theconnector needle 170 causes deflection of the resilient septum 130.

In the depicted embodiment, the coupling of the male connector body 162with the female connector body 122 can take place by pressing andsnapping the male connector body 162 into the female connector body 122.That is, an axial compression force, such as a force applied by thethumb of a healthcare worker (refer to FIG. 1), can cause the maleconnector body 162 to be pressed and snapped into a fully seatedarrangement with the female connector body 122. Accordingly, thecoupling of the male connector body 162 with the female connector body122 can be performed using a one-handed technique. Once fully seated,the arrangement can provide a substantial resistance to decoupling so asto meeting all applicable standards and regulatory requirements for sucha device.

To facilitate a snap-together engagement technique, in some embodimentsthe male connector body 162 and the female connector body 122 havecomplementary structural features that snap into engagement with eachother. For example, in the depicted embodiment the male connector body162 has a proximal annular protrusion 164 and a distal annularprotrusion 166. The female connector body 122, in turn, has a proximalannular recess 124 and a distal annular recess 126. As best seen in FIG.2B, the proximal annular recess 124 receives the proximal annularprotrusion 164, and the distal annular recess 126 receives the distalannular protrusion 166. When the proximal annular protrusion 164 isseated in the proximal annular recess 124, and the distal annularprotrusion 166 is seated in the distal annular recess 126, the tip ofthe connector needle 170 has been forced all the way through theresilient septum 130, and the vascular access device 100 is functionalfor infusing liquids to the blood vessel 20 or withdrawing blood fromthe blood vessel 20. While in the depicted embodiment the male connectorbody 162 and the female connector body 122 have two complementaryannular protrusions/recesses, in some embodiments only one complementaryannular protrusion/recess is included. In some embodiments, three ormore complementary annular protrusions/recesses are included.

While the depicted embodiment facilitates snap-together coupling betweenthe male connector body 162 and the female connector body 122, in someembodiments the male connector body 162 and the female connector body122 are configured to be coupled together in other manners. For example,in some embodiments the male connector body 162 and the female connectorbody 122 are configured to be coupled together in manners such as, butnot limited to, screwing together, pivoting together, laterally slidingtogether (e.g., using a dovetail or tongue-in-groove arrangement), andthe like, and combinations thereof.

Still referring to FIGS. 1 and 2A-B, the catheter assembly 110 includesthe female connector body 122, the resilient septum 130, and thecatheter tube 140. These components can be attached to each other usingvarious techniques. For example, in some embodiments one or more of thefemale connector body 122, the resilient septum 130, and the cathetertube 140 are joined to each other using an adhesive. In someembodiments, one or more of the female connector body 122, the resilientseptum 130, and the catheter tube 140 are joined to each other using aheat-staking technique. In some embodiments, one or more of the femaleconnector body 122, the resilient septum 130, and the catheter tube 140are joined to each other by a molding process (e.g., insert molding,overmolding, and the like). In some embodiments, other joiningtechniques, such as, but not limited to ultrasonic welding, solventbonding, radio-frequency welding, press-fitting, pinning, and the like,and combinations thereof, are used to join one or more of the femaleconnector body 122, the resilient septum 130, and the catheter tube 140to each other.

In some embodiments, the female connector body 122 comprises a flexiblematerial such as, but not limited to, silicone, high durometer rubber,polyurethane, styrenics, copolyesters, polyamides, polyolefin blends,polyolefin alloys, reactor TPOs, polyolefin plastomers, polyolefinelastomers, and the like. The relative flexibility of the femaleconnector body 122 (as compared to the male connector body 162) canfacilitate the snap-together coupling between the male connector body162 and the female connector body 122. For example, in some embodimentsas the male connector body 162 is pressed into the female connector body122, the female connector body 122 can flex, stretch, and/or expand toallow the proximal annular protrusion 164 and the distal annularprotrusion 166 to pass through on their way to being seated in theproximal annular recess 124 and the distal annular recess 126.

Optionally, in some embodiments, the female connector body 122 has wingswith suture attachment holes/features for securement of the femaleconnector body 122 to the skin 10 of the patient. In some embodiments,the female connector body 122 does not include wings. In particularembodiments, the female connector body 122 is color-coded incorrespondence with the size (e.g., gauge and/or length) of the cathetertube 140.

The female connector body 122 includes a distal end portion 123. In someembodiments, the distal end portion 123 comprises a transparent oressentially transparent material. In some embodiments, the distal endportion 123 includes one or more transparent or essentially transparentwindow portions. While in some embodiments the distal end portion 123 ismade of a different material than the rest of the female connector body122, in some embodiments the distal end portion 123 is made of the samematerial as the rest of the female connector body 122. The transparencyof at least a portion of the distal end portion 123 facilitatesvisualization by a healthcare worker of the presence of blood in distalinterior space 121 a, which is known as flashback detection. Flashbackdetection facilitates confirmation that at least the distal end portionof the catheter tube 140 is within a blood vessel as desired.

The catheter assembly 110 also includes the resilient septum 130. Insome embodiments, the resilient septum 130 comprises a flexible materialsuch as, but not limited to, silicone, polyurethane, rubber, nitrilerubber, polytetrafluoroethylene, and the like. In some embodiments, theresilient septum 130 comprises a biocompatible gel or semi-solidmaterial.

The catheter assembly 110 also includes the catheter tube 140. In someembodiments, the catheter tube 140 comprises polyurethane, fluorinatedethylene propylene (FEP), silicones, nylon, nitinol, and the like. Insome embodiments, the catheter tube 140 is treated to increase itslubricity.

The connector assembly 160 includes the male connector body 162, theconnector needle 170, and the connector tube 180. The components of theconnector assembly 160 can be attached together using any of thetechniques described above in reference to the catheter assembly 110.

In some embodiments, the male connector body 162 can comprise a materialsuch as polycarbonate, polyvinylchloride, polyurethanes, silicones,other thermoplastic elastomers, and the like. In particular embodiments,the male connector body 162 is transparent or essentially transparent.As such, the open interior space 161 can serve as a flash chamber toassist the healthcare worker to detect a proper result during theprocess of coupling the connector assembly 160 with the catheterassembly 110. In the depicted embodiment, the proximal annularprotrusion 164 and the distal annular protrusion 166 are integralstructural features of the male connector body 162 that have been moldedin a unitary manner with the other portions of the male connector body162. In some embodiments, the proximal annular protrusion 164 and/or thedistal annular protrusion 166 are distinguished from the other portionsof the male connector body 162 by virtue of being made from another typeof material. For example, in some embodiments the proximal annularprotrusion 164 and/or the distal annular protrusion 166 are ringcomponents that get attached to the other portions of the male connectorbody 162. Consequently, in some embodiments the proximal annularprotrusion 164 and/or the distal annular protrusion 166 can be made of adifferent material than the other portions of the male connector body162 are made of. For example, in some such embodiments the proximalannular protrusion 164 and/or the distal annular protrusion 166 are madeof a softer or more flexible material than the other portions of themale connector body 162.

The connector assembly 160 also includes the connector needle 170. Theconnector needle 170 can comprise a material such as, but not limitedto, stainless steel, steel alloys, polymeric materials, and the like. Inthe depicted embodiment, the connector needle 170 has a non-coringneedle tip design. For example, the opening at the tip of the connectorneedle 170 faces radially outward (rather than axially outward).Accordingly, when a healthcare worker presses the male connector body162 into the female connector body 122, the tip of the connector needle170 can pierce through the resilient septum 130 without creating a core(plug) that could occlude the connector needle 170. In some embodiments,the connector needle 170 may include one or more barbs.

The connector assembly 160 also includes the connector tube 180. One ofordinary skill in the art will understand that while one end of theconnector tube 180 is attached to the male connector body 162, the otherend of the connector tube 180 can be attached to a variety of types offittings, containers, devices, and the like.

Referring now to FIGS. 3A-C, the vascular access device 100 can includea combination of the catheter assembly 110, a secondary instrument (suchas the connector assembly 160 in this embodiment), and the introducerneedle assembly 300 (which can removably pre-installed within thecatheter assembly 110 as part of a packaged kit). As previouslydescribed, the secondary instrument (such as the connector assembly 160in this embodiment) can be releasably mated to the catheter assembly 110after the introducer needle assembly 300 is withdrawn. As describedfurther herein, some embodiments of the installation method can beperformed by the healthcare worker, optionally, using a single hand.

In this embodiment, the introducer needle assembly 300 and/or thecatheter assembly 110 are coupled with a protective sheath 360 that isconfigured to cover at least the sharp tip of the introducer needle. Theintroducer needle assembly 300 and the protective sheath 360 as shown inFIG. 3A are configured together as a healthcare worker would receive andinitially handle them (other than sterile packaging, not shown) prior toinstalling the vascular access device 100. The protective sheath 360covers the introducer needle assembly 300 to reduce the likelihood ofaccidental needle sticks. Prior to installing the catheter assembly 110into the patient using the introducer needle assembly 300, thehealthcare worker removes the protective sheath 360 and discards it.

In this embodiment, the introducer needle assembly 300 includes theintroducer needle 310, a needle guard 320, and an introducer needle hub330. The introducer needle 310 is fixedly coupled to and extending fromthe introducer needle hub 330. The introducer needle hub 330 is slidablycoupled with the needle guard 320. The slidable relationship between theneedle guard 320 and introducer needle hub 330 is represented by arrow340.

As shown in FIG. 3B, the introducer needle 310 is a sharp, hollow needlethat is used to pierce through the patient's skin 10 to access the bloodvessel 20. The catheter assembly 110 is slidably coupled on theintroducer needle 310. To install the catheter assembly 110, thehealthcare worker inserts the distal tip of the introducer needle 310through the patient's skin 10 and positions the distal tip of theintroducer needle 310 in the blood vessel 20. In doing so, the distaltip of the catheter assembly 110 is also inserted into the blood vessel20. When the distal tip of the introducer needle 310 is in the bloodvessel 20, some blood will flow into the lumen of the introducer needle310 and collect in a flash chamber 334 of the introducer needle hub 330.The rear of the flash chamber 334 is plugged by a microporous plug 336that allows air to escape the flash chamber 334 while containing bloodwithin the flash chamber 334. The presence of blood in the flash chamber334 provides a visual indication to the healthcare worker that theintroducer needle 310 (and the catheter assembly 110 by association) isproperly positioned within the blood vessel 20.

After insertion of the introducer needle 310, the healthcare workerslides the introducer needle hub 330 away from the patient's skin 10 asindicated by arrow 340. In some embodiments, contoured portions 332 onthe introducer needle hub 330 can be provided to assist the healthcareworker during this step. During the sliding of the introducer needle hub330, the healthcare worker maintains the position of the needle guard320 generally stationary in relation to the patient. Doing so withdrawsthe introducer needle 310 into the safe confines of the needle guard320, while maintaining the catheter assembly 110 in a proper position inrelation to the patient. A push-off tab 322 that is located at thedistal end of the needle guard 320 and/or surface features 324 on theneedle guard 320 can also be used by the healthcare worker to assistwith the performance of this step. Accordingly, if desired, this stepcan be performed by the healthcare worker using a single hand.

When the healthcare worker has completed sliding the introducer needlehub 330 away from the patient's skin 10 as indicated by arrow 340 (suchthat the introducer needle 310 is fully within the needle guard 320),the healthcare worker can then separate the introducer needle assembly300 from the catheter assembly 110 (refer to FIG. 3C). The sharp tip ofthe introducer needle 310 will be retained (e.g., locked) within theneedle guard 320 so as to protect the healthcare worker (and others)from accidental needle sticks from a contaminated needle. The introducerneedle assembly 300 can then be properly discarded while the needle 310is safely covered.

As described above, due to the resilient septum 130 in the catheterassembly 110, essentially no blood will leak through the lumen of thecatheter assembly 110 after separation of the introducer needle assembly300 from the catheter assembly 110. Again, this feature can eliminatethe need for the healthcare worker to apply a tamponade pressure on theskin surface 10 of the patient prior to coupling the connector assembly160 with the catheter assembly 110. As such, the vascular access device100 can be optionally installed using the previously describedone-handed installation method.

The connector assembly 160 can then be coupled with the catheterassembly 110, as indicated by phantom line 370. In the depictedembodiment, the connector assembly 160 and the catheter assembly 110 areconfigured for snap-together coupling. Therefore, to couple theconnector assembly 160 and the catheter assembly 110 together, thehealthcare worker can simply press the male connector body 162 into thefemale connector body 122 so that the proximal annular protrusion 164 isseated in the proximal annular recess 124, and the distal annularprotrusion 166 is seated in the distal annular recess 126 (refer toFIGS. 1, 2A, and 2B). This step can be performed using a one-handedinstallation method. When the connector assembly 160 and the catheterassembly 110 have been properly coupled together (e.g., snappedtogether), and the distal tip of the catheter assembly 110 is properlywithin the blood vessel 20, the open interior space 161 that serves as aflash chamber of the connector assembly may contain some blood. Thepresence of blood in the open interior space 161 is an indication to thehealthcare worker that the vascular access device 100 has been properlyinstalled.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the scope of the invention. Accordingly,other embodiments are within the scope of the following claims.

What is claimed is:
 1. A method of installing a vascular access device,comprising: piercing a distal tip of an introducer needle through a skinsurface and positioning the distal tip in a blood vessel while theintroducer needle is slidably disposed with a lumen of a catheterassembly such that a distal tip of the catheter assembly is alsopositioned in the blood vessel; withdrawing the introducer needle fromthe patient while leaving the catheter assembly positioned in the bloodvessel, wherein the introducer needle is slidably withdrawn through asealing septum housed within the catheter assembly such that the septumseals a blood flow path through the catheter assembly after theintroducer needle disengages the septum and the catheter assembly; andmounting a connector assembly with the catheter assembly into anoperative configuration by pressing a connector body of the connectorassembly into engagement with a catheter hub of the catheter assembly sothat a connector needle of the connector assembly penetrates through thesealing septum previously occupied by the introducer needle.
 2. Themethod of claim 1, wherein the connector needle extends through thesealing septum without deflecting an outer periphery of the sealingseptum.
 3. The method of claim 2, wherein the connector needlepenetrates the sealing septum at substantially the same location fromwhich the introducer needle is withdrawn from the sealing septum.
 4. Themethod of claim 1, wherein said piercing, said withdrawing, and saidmounting are performed using a single hand.
 5. The method of claim 4,wherein the pressing the connector body into engagement with thecatheter hub comprises snapping the connector body and the catheter hubtogether.
 6. The method of claim 5, wherein the pressing the connectorbody into engagement with the catheter hub snaps the connector bodytogether with the catheter hub when an annular protrusion that extendsaround an entire circumference of the connector body seats within anannular recess that extends along an entire circumference of thecatheter hub.
 7. The method of claim 1, wherein said piercing, saidwithdrawing, and said mounting are performed to provide peripheralintravenous access to the blood vessel.
 8. The method of claim 1,further comprising infusing fluid into the blood vessel through theconnector assembly and the catheter assembly.
 9. The method of claim 8,further comprising infusing fluid into the blood vessel through theconnector needle.
 10. The method of claim 1, wherein the connectorneedle is comprises a non-coring tip
 11. The method of claim 1, wherein:the catheter assembly comprises (i) the catheter hub, (ii) a cathetertube extending distally from the catheter hub and said lumen that isconfigured to be positioned in the blood vessel, and (iii) the sealingseptum disposed within an interior space defined by the catheter hub;and the introducer needle is attached to and extends from an introducerneedle hub which is slidably coupled to a needle guard, and a distal endof the needle guard is removably connected to a proximal end of thecatheter hub during said piercing of the distal tip of the introducerneedle through the skin surface.
 12. The method of claim 11, whereinsaid withdrawing the introducer needle from the patient causes thedistal tip of the introducer needle to move in a proximal direction to aposition inside the needle guard.
 13. The method of claim 12, furthercomprising, after withdrawing the introducer needle from the patient,detaching the needle guard from the proximal end of the catheter hubwhile the distal tip of the introducer needle is contained inside theneedle guard.
 14. The method of claim 13, wherein said mounting theconnector assembly with the catheter assembly into the operativeconfiguration comprises pressing the connector body of the connectorassembly into engagement with the proximal end of the catheter hub aftersaid detaching the needle guard from the proximal end of the catheterhub.
 15. The method of claim 14, wherein the catheter hub comprises anannular recess that extends along an entire circumference of thecatheter hub and the connector body comprises an annular protrusion thatextends along an entire circumference of the connector body, the annularrecess and the annular protrusion having complementary shapes to matingwith one another.
 16. The method of claim 14, wherein the catheter hubdeflects as the connector body is pressed into a mated condition withthe catheter hub.
 17. The method of claim 16, wherein the catheter hubdeflects as the connector body is pressed into the mated condition withthe catheter hub because an outer circumferential diameter of theconnector body including a protrusion on the connector body is largerthan an inner circumferential diameter of at least a portion of thecatheter hub.
 18. The method of claim 13, wherein said withdrawing theintroducer needle and detaching the needle guard from the proximal endof the catheter hub while the distal tip of the introducer needle iscontained inside the needle guard are performed using a single hand. 19.The method of claim 13, wherein said pressing the connector body of theconnector assembly into engagement with the proximal end of the catheterhub causes the connector needle to extend through the sealing septumwithout deflecting an outer periphery of the sealing septum.
 20. Themethod of claim 19, wherein the connector needle penetrates the sealingseptum at substantially the same location from which the introducerneedle is withdrawn from the sealing septum.